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Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

Primary Purpose

Chronic Renal Failure

Status

Unknown status

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

heparin sodium

About this trial

This is an interventional prevention trial for Chronic Renal Failure focused on measuring heparin, renal insufficiency, chronic, extracorporeal dialysis, fibrinolytic agents, anticoagulants, aPTT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients research that agree to participate in the study and sign the informed consent form;
Patients aged over 18 years, both sexes, regardless of color or social class;
Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
Patients with laboratory results within specified acceptance criteria.

Exclusion Criteria:

Patients who are taking part or took part in another clinical investigational study within 12 months;
Hypersensitivity to heparin sodium and/or benzyl alcohol;
History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
Severe liver disease;
Patients in cancer treatment;
Pregnant and lactating women;
Use of glucocorticoids over physiological dose;
Use of other anticoagulants;
Patients undergoing any surgery performed less than 15 days;
History of non response or exacerbated response to heparin sodium;
Patients who do not adapt to 150 UI/kg dose.

Sites / Locations

Instituto de Nefrologia de Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Actparin® - Laboratorio Bergamo

Heparin sodium - APP Pharmaceuticals

Arm Description

Outcomes

Primary Outcome Measures

Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis

Secondary Outcome Measures

Pharmacodynamic activity of heparin observed through aPTT marker

Safety in use of heparin by monitoring adverse events

Full Information

NCT ID

NCT01346215

First Posted

April 28, 2011

Last Updated

April 29, 2011

Sponsor

Laboratório Químico Farmacêutico Bergamo Ltda.

Collaborators

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT01346215

Brief Title

Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

Official Title

Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Laboratório Químico Farmacêutico Bergamo Ltda.

Collaborators

Azidus Brasil

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure

Keywords

heparin, renal insufficiency, chronic, extracorporeal dialysis, fibrinolytic agents, anticoagulants, aPTT

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Actparin® - Laboratorio Bergamo

Arm Type

Experimental

Arm Title

Heparin sodium - APP Pharmaceuticals

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

heparin sodium

Intervention Description

5000 UI/mL

Intervention Type

Biological

Intervention Name(s)

heparin sodium

Intervention Description

5000 UI/mL

Primary Outcome Measure Information:

Title

Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis

Time Frame

4 weeks (12 consecutive sessions)

Secondary Outcome Measure Information:

Title

Pharmacodynamic activity of heparin observed through aPTT marker

Time Frame

4 weeks (sessions 1, 6 and 12)

Title

Safety in use of heparin by monitoring adverse events

Time Frame

5 weeks (12 consecutive sessions + 1 post treatment session)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients research that agree to participate in the study and sign the informed consent form; Patients aged over 18 years, both sexes, regardless of color or social class; Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system; Patients with laboratory results within specified acceptance criteria. Exclusion Criteria: Patients who are taking part or took part in another clinical investigational study within 12 months; Hypersensitivity to heparin sodium and/or benzyl alcohol; History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system; History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer; Severe liver disease; Patients in cancer treatment; Pregnant and lactating women; Use of glucocorticoids over physiological dose; Use of other anticoagulants; Patients undergoing any surgery performed less than 15 days; History of non response or exacerbated response to heparin sodium; Patients who do not adapt to 150 UI/kg dose.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcelo A. C. Orlandi, Dr.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcelo A. C. Orlandi, Dr.

Organizational Affiliation

Instituto de Nefrologia de Campinas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Nefrologia de Campinas

City

Campinas

State/Province

São Paulo

Country

Brazil

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcelo Orlandi

12. IPD Sharing Statement

Links:

URL

http://www.nlm.nih.gov/medlineplus/

Description

MedlinePlus

URL

http://www.nlm.nih.gov/medlineplus/bloodthinners.html

Description

Blood thinners

URL

http://www.nlm.nih.gov/medlineplus/dialysis.html

Description

Dialysis

URL

http://www.nlm.nih.gov/medlineplus/kidneyfailure.html

Description

Kidney failure

URL

http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

Description

Drug Information

URL

http://druginfo.nlm.nih.gov/drugportal/dpdirect.jsp?name=Heparin

Description

Heparin

URL

http://clinicaltrials.gov/ct2/info/fdalinks

Description

U.S. FDA Resources

Learn more about this trial

Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

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